Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients

NCT03757182 | Active Not Recruiting

• 1 other identifier: IIT2018-19-GRESH-DIGISTEP
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer. Findings from this study will help us better understand how change in daily physical activity, as measured using the wearable activity monitor, is related to change in a patient's functional status and clinical condition.

Conditions

Cancer; Cancer, Metastatic; Neoplasms

Keywords

Wearable device; Fitness tracker; Wearable activity monitor; Biosensor; Performance Status; Activity Monitoring

Outcome Measures

Primary Outcomes (2)

• Absolute change in average step counts at 8 weeks from baseline

  Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit

  8 weeks

• Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline

  Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG. ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death. Only one rating of ECOG PS by provider is completed at each timepoint.

  8 weeks

Secondary Outcomes (6)

• Absolute change in patient-reported physical function at 8 weeks from baseline

  8 weeks

• Patient weekly distress levels up to 8 weeks from baseline

  8 weeks

• Adherence to wearing the device for the specified study period

  8 weeks

• Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)

  8 weeks

• Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks

  up to 12 weeks

Study Arms (1)

Wearable activity monitor

Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.

Other: Wearable activity monitor

Interventions

Wearable activity monitor OTHER

Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)

Also known as: Fitness tracker, Wearable device, Biosensor

Wearable activity monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stage 3/4 advanced cancer patients being seen for treatment at Cedars-Sinai Medical Center.

You may qualify if:

• Diagnosis of advanced (stage 3 or 4) cancer of any type
• Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
• Access to a device that has the capability to sync to the Fitbit
• Expected to have standard of care oncology appointments at least once every 8 weeks (+/-7 days).
• Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
• English or Spanish speaking
• Ability to consent
• Informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You may not qualify if:

• Allergy to surgical steel or elastomer/rubber
• Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Fitness Trackers; Wearable Electronic Devices; Biosensing Techniques

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Electrical Equipment and Supplies; Molecular Probe Techniques; Investigative Techniques

Study Officials

• Gillian Gresham, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: December 5, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

US (1)